Arthrex® AR-8944CL-LSRecalls & reported problems
Arthrex, Inc. · LO-PRO MTP PLT,CONTRD,LNG,L,TI, STRL · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867052895), received between Oct 28, 2020 and Oct 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2020Break
IT WAS REPORTED THAT 6 MONTHS AGO AN ARTHRODESE WAS PERFORMED WITH THE MTP PLATE AND INNOTERE CYLINDER WITH AN OVERWEIGHT PATIENT. NOW IT WAS REPORTED THAT THE PLATE IS BROKEN AND A REVISION SURGERY WAS DONE. UPDATE 14-OCT-2020 FURTHER INFORMATION OBTAINED: THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2020. THE REVISION SURGERY WAS SUCCESSFULLY PERFORMED ON (B)(6) 2020. UPDATE 15-OCT-2020: REVISION SURGERY WAS FINISHED SUCCESSFULLY WITH SPONGIOSA WAS REMOVED FROM THE ILIAC CREST, INSERTED INTO THE FOOT AND FIXED WITH SCREWS.
Patient problems: Insufficient Information
MAUDE report 10746321 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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